BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    MDR report key: 2183282 · Received July 28, 2011

    Report

    Report Number
    3002648230-2011-00103
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT IS SIMILAR TO THE ARCTIC FRONT CARDIAC CRYOABLATION CATHETER MARKETED IN THE US. THE PRODUCT WAS RETURNED AND INVESTIGATED AS FOLLOWS: VISUAL INSPECTION SHOWED THE PRESENCE OF BLOOD IN THE CATHETER. FUNCTIONAL TESTS WERE PERFORMED: PRESSURE TEST REVEALED A LEAK THROUGH THE GUIDE WIRE LUMEN. DISSECTION SHOWED A GUIDE WIRE LUMEN PARTIAL SNAPPING AT THE COIL, LOCATED IN THE AREA BENEATH THE BALLOON. HOWEVER, THE BALLOON INTEGRITY WAS INTACT WITH NO BREACH. ITEMS 1 AND 2 DESCRIBED ABOVE TRIGGERED THE FAIL-SAFE SYSTEM (SYSTEM NOTICE MESSAGE 50006) AND STOPPED THE INJECTION. A CORRECTIVE ACTION WAS INITIATED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    DURING A CRYOABLATION PROCEDURE PERFORMED IN (B)(6), SYSTEM NOTICE MESSAGE 50006 (THE SAFETY SYSTEM HAS DETECTED BLOOD IN THE CATHETER HANDLE, STOPPED THE INJECTION AND DISABLED THE VACUUM) WAS TRIGGERED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC FRONT CARDIAC CRYOABLATION CATHETER OAE MEDTRONIC CRYOCATH LP 2AF231 19910

    Patients

    Seq Age Sex Outcome Treatment
    1